MEDICAL ACTION INDUSTRIES - MEDICAL ACTION INDUSTRIES INC.

Duns Number:092364462

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More Product Details

Catalog Number

-

Brand Name

MEDICAL ACTION INDUSTRIES

Version/Model Number

86153

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GAX

Product Code Name

TOURNIQUET, NONPNEUMATIC

Device Record Status

Public Device Record Key

20a9ea7c-67a0-4615-b419-cdca69b3d329

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICAL ACTION INDUSTRIES INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 548
2 A medical device with a moderate to high risk that requires special controls. 2798
U Unclassified 1